A Study Of PF-03732010 In Patients With Advanced Solid Tumors
2012년 2월 21일 업데이트: Pfizer
A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of PF-03732010 In Patients With Advanced Solid Tumors
P-cadherin may play a part in tumor growth; PF-03732010 is a new drug that inhibits P-cadherin.
This study will test how well the drug is tolerated, and what effects there might be.
Blood will also be taken to measure the amount of drug in blood.
연구 개요
연구 유형
중재적
등록 (실제)
43
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Advanced solid tumors refractory to (or intolerant of) established therapy known to provide clinical benefit, or for which there is no standard therapy
- Age >= 18 years of age
- Adequate bone marrow function as defined by: absolute neutrophil count (ANC) ≥1500/uL, hemoglobin ≥ 9 g/dL, platelets > 100,000/uL
- Adequate liver function as defined by: bilirubin < 1.5 x ULN, AST, ALT and ALP < 2.5 x ULN, or < 5 x ULN with documented liver and/or bone metastases
- Serum creatinine < 1.5 x ULN
- ECOG status 0-1
- Availability of biopsy tumor tissue (or fine needle aspirate) for testing of P-cadherin expression
- Tumor tissue (or fine needle aspirate) showing over-expression of P-cadherin
- Must be able to give written informed consent
- Be able to comply with scheduled study visits, treatment plans, laboratory tests and other procedures
Exclusion Criteria:
- Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of study entry
- Patients with carcinomatous meningitis or untreated brain metastases.
- History of significant low platelet count, and/or bleeding disorders, requiring medical or surgical intervention
- History of significant bleeding episodes within 6 months, unless the source of bleeding has been resected
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: PF-03732010
Single Arm study
|
IV infusion.
Escalating dose levels, starting at 0.5 mg/kg to Maximum Tolerated Dose.
Cycle length of 4 weeks for first cycle, and 2 weekly for subsequently cycles was originally explored, yet based on emerging PK data the Cycle 1 duration is 2 weeks and then weekly.
Number of Cycles: Until Progression or unacceptable toxicity develops.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Maximum Tolerated Dose (MTD)
기간: Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle
|
Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle
|
|
Recommended Phase-2 Dose (RP2D)
기간: Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle
|
Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)]
기간: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
AUC (0-28 day)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-28 day).
|
0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
|
Time to Reach Maximum Observed Serum Concentration (Tmax)
기간: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
|
|
Minimum Observed Serum Trough Concentration (Cmin)
기간: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
|
|
Maximum Observed Serum Concentration (Cmax)
기간: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-14 Day)]
기간: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
AUC (0-14)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-14 day).
|
0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
기간: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
|
0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
|
Clearance (CL)
기간: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
|
0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
|
Apparent Volume of Distribution (Vd)
기간: 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
|
0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
|
|
Number of Participants With Objective Response of Complete Response or Partial Response
기간: Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37
|
Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.
PR are those with at least 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
|
Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Human Anti-Human Antibody (HAHA) Levels
기간: Pre-dose on Day 1 of Cycle 2 and Day 1 of every other cycle up to Week 4, 8 and 12 after the last dose or withdrawal
|
HAHA are indicators of immunogenicity to PF-03732010.
|
Pre-dose on Day 1 of Cycle 2 and Day 1 of every other cycle up to Week 4, 8 and 12 after the last dose or withdrawal
|
|
Change From Baseline in Standardized Uptake Values (SUV) of 18F-fluoro-3'-Deoxy-3'-L-fluorothymidine Positron Emission Tomography (FLT-PET)
기간: Baseline, cycle 3 and after 8 weeks
|
Baseline, cycle 3 and after 8 weeks
|
|
|
Time to Disease Progression
기간: Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37
|
Time in weeks from start of study treatment to first documentation of objective disease progression or death due to disease, whichever comes first.
|
Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37
|
|
Change From Baseline in Circulating Tumor Cells (CTC) Concentration in Blood
기간: Pre-dose (baseline), Day 8 cycle 1, Day 1 Cycle 2 and Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal
|
Pre-dose (baseline), Day 8 cycle 1, Day 1 Cycle 2 and Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal
|
|
|
Change From Baseline in Leucocyte Subtypes
기간: Baseline, Day 1 cycle 1, Day 1 Cycle 2, Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal
|
Baseline, Day 1 cycle 1, Day 1 Cycle 2, Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal
|
|
|
Change From Baseline in Cytokine Concentration
기간: Pre-dose (baseline), 1, 6 and 24 hrs after start of infusion on Day 1 cycle 1
|
Pre-dose (baseline), 1, 6 and 24 hrs after start of infusion on Day 1 cycle 1
|
|
|
Change From Baseline in Tumor Proteins Related to P-cadherin Signaling and/or Tumor Proliferation or Apoptosis by Immunohistochemistry (IHC)
기간: Baseline and cycle 3
|
Baseline and cycle 3
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2007년 12월 1일
기본 완료 (실제)
2011년 2월 1일
연구 완료 (실제)
2011년 2월 1일
연구 등록 날짜
최초 제출
2007년 11월 12일
QC 기준을 충족하는 최초 제출
2007년 11월 12일
처음 게시됨 (추정)
2007년 11월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 3월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 2월 21일
마지막으로 확인됨
2012년 2월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- A9301001
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
PF-03732010에 대한 임상 시험
-
Pfizer완전한